ComboCap, Inc. wrapped up an exciting 2017 with big successes in our manufacturing capabilities. We’ve been producing and selling in the market since the beginning of 2017 at full capacity. Toward the end of last year we added a second manufacturing line.
We’ve been running our own operation with two production lines within our contract manufacturer’s site in Chadds Ford, PA just outside of Philadelphia. We have four more lines built and ready for dispatch from our Tech and Equipment Center in Cape Town, South Africa. Operating and bringing new technology to market within a contract manufacturer was the right decision for our early launch but has become restricting on growth and also raises IP protection concerns. We’ve therefore secured and signed the lease for our own 50,000 sf stand-alone ComboCap plant in New Jersey, which will be up and running with six production lines by the end of Q2 2018. It will have an initial rated capacity of 15 million units per month with maximum capacity of 80 to 100 million units per month estimated to be reached between 2020 and 2024.
The site formerly housed an industry-leading organization providing turnkey contract packaging, repackaging and manufacturing solutions for the pharmaceutical, OTC, dietary supplements, animal health, consumer health and medical device markets. As with the former occupant, ComboCap, Inc. plans to continue the standards that have been established for this location. Our personnel, equipment and facilities will be guided by exacting processes and procedures. The facilities are all FDA registered. The FDA’s current Good Manufacturing Practice (cGMP) will govern standard operating procedures. Our organization will meet and exceed FDA standards for 21 CFR, Parts 210 and 211, 21 CFR 820, and 21 CFR 111. ComboCap fully intends to use this facility to produce our OTC and Rx ComboCap Products in addition to the nutraceutical products we are currently making.